Flexible tissue removal devices and methods

ABSTRACT

A device for removing tissue from a patient may include an elongate flexible body having a proximal end, a distal end, and a longitudinal axis therebetween, the elongate body having opposed first and second major surfaces with a lateral orientation across the axis, and a plurality of blades distributed laterally across the first major surface. Each blade may have a first end adjacent the first surface and extending to a cantilevered second end, a first edge between the first and second ends of the blade being oriented toward the distal end of the elongate body, a second edge between the first and second ends of the blade being oriented toward the proximal end of the elongate body, a height of the blade between its first and second ends, and an axial length of the blade between its first and second edges.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/267,683, titled “Flexible Tissue Removal Devices andMethods,” filed Oct. 6, 2011, Publication No. US-2012-0022538-A1, whichis a continuation of U.S. patent application Ser. No. 11/687,558, titled“Flexible Tissue Removal Devices and Methods,” filed Mar. 16, 2007, nowU.S. Pat. No. 8,062,298, which is a continuation-in-part of U.S. patentapplication Ser. No. 11/429,377, titled “Flexible Tissue Rasp,” filedMay 4, 2006, now U.S. Pat. No. 8,048,080, each of which is hereinincorporated by reference in its entirety. U.S. patent application Ser.No. 11/687,558 also claims priority from U.S. Provisional PatentApplication Ser. No. 60/869,070, titled “Flexible Tissue Removal Devicesand Methods,” filed Dec. 7, 2006, which is herein incorporated byreference in its entirety.

The present application is related to, but does not claim priority from,PCT Patent Application Pub. No. PCT/US2005/037136, titled “Devices andMethods for Selective Surgical Removal of Tissue, filed Oct. 15, 2005,which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to medical/surgical devices andmethods. More specifically, the present invention relates to flexibletissue modification devices and methods.

A significant number of surgical procedures involve modifying tissue ina patient's body, such as by removing, cutting, shaving, abrading,shrinking, ablating or otherwise modifying tissue. Minimally invasive(or “less invasive”) surgical procedures often involve modifying tissuethrough one or more small incisions or percutaneous access, and thus maybe more technically challenging procedures. Some of the challenges ofminimally invasive tissue modification procedures include working in asmaller operating field, working with smaller devices, and trying tooperate with reduced or even no direct visualization of the tissue (ortissues) being modified. For example, using arthroscopic surgicaltechniques for repairing joints such as the knee or the shoulder, it maybe quite challenging to modify certain tissues to achieve a desiredresult, due to the required small size of arthroscopic instruments, theconfined surgical space of the joint, lack of direct visualization ofthe surgical space, and the like. It may be particularly challenging insome surgical procedures, for example, to cut or contour bone orligamentous tissue with currently available minimally invasive tools andtechniques. For example, trying to shave a thin slice of bone off acurved bony surface, using a small-diameter tool in a confined spacewith little or no ability to see the surface being cut, as may berequired in some procedures, may be incredibly challenging or evenimpossible using currently available devices.

One area of surgery which would likely benefit from the development ofless invasive techniques is the treatment of spinal stenosis. Spinalstenosis occurs when nerve tissue and/or the blood vessels supplyingnerve tissue in the spine become impinged by one or more structurespressing against them, causing symptoms. The most common form of spinalstenosis occurs in the lower (or lumbar) spine and can cause severepain, numbness and/or loss of function in the lower back and/or one orboth lower limb.

FIG. 1 is a top view of a vertebra with the cauda equina (the bundle ofnerves that extends from the base of the spinal cord) shown in crosssection and two nerve roots branching from the cauda equina to exit thecentral spinal canal and extend through intervertebral foramina oneither side of the vertebra. Spinal stenosis can occur when the spinalcord, cauda equina and/or nerve root(s) are impinged by one or moretissues in the spine, such as buckled or thickened ligamentum flavum,hypertrophied facet joint (shown as superior articular processes in FIG.1), osteophytes (or “bone spurs”) on vertebrae, spondylolisthesis(sliding of one vertebra relative to an adjacent vertebra), facet jointsynovial cysts, and/or collapse, bulging or herniation of anintervertebral disc. Impingement of neural and/or neurovascular tissuein the spine by one or more of these tissues may cause pain, numbnessand/or loss of strength or mobility in one or both of a patient's lowerlimbs and/or of the patient's back.

In the United States, spinal stenosis occurs with an incidence ofbetween 4% and 6% (or more) of adults aged 50 and older and is the mostfrequent reason cited for back surgery in patients aged 60 and older.Patients suffering from spinal stenosis are typically first treated withconservative approaches such as exercise therapy, analgesics,anti-inflammatory medications, and epidural steroid injections. Whenthese conservative treatment options fail and symptoms are severe, as isfrequently the case, surgery may be required to remove impinging tissueand decompress the impinged nerve tissue.

Lumbar spinal stenosis surgery involves first making an incision in theback and stripping muscles and supporting structures away from the spineto expose the posterior aspect of the vertebral column. Thickenedligamentum flavum is then exposed by complete or partial removal of thebony arch (lamina) covering the back of the spinal canal (laminectomy orlaminotomy). In addition, the surgery often includes partial or completefacetectomy (removal of all or part of one or more facet joints), toremove impinging ligamentum flavum or bone tissue. Spinal stenosissurgery is performed under general anesthesia, and patients are usuallyadmitted to the hospital for five to seven days after surgery, with fullrecovery from surgery requiring between six weeks and three months. Manypatients need extended therapy at a rehabilitation facility to regainenough mobility to live independently.

Removal of vertebral bone, as occurs in laminectomy and facetectomy,often leaves the effected area of the spine very unstable, leading to aneed for an additional highly invasive fusion procedure that puts extrademands on the patient's vertebrae and limits the patient's ability tomove. Unfortunately, a surgical spine fusion results in a loss ofability to move the fused section of the back, diminishing the patient'srange of motion and causing stress on the discs and facet joints ofadjacent vertebral segments. Such stress on adjacent vertebrae oftenleads to further dysfunction of the spine, back pain, lower leg weaknessor pain, and/or other symptoms. Furthermore, using current surgicaltechniques, gaining sufficient access to the spine to perform alaminectomy, facetectomy and spinal fusion requires dissecting through awide incision on the back and typically causes extensive muscle damage,leading to significant post-operative pain and lengthy rehabilitation.Thus, while laminectomy, facetectomy, and spinal fusion frequentlyimprove symptoms of neural and neurovascular impingement in the shortterm, these procedures are highly invasive, diminish spinal function,drastically disrupt normal anatomy, and increase long-term morbidityabove levels seen in untreated patients.

Therefore, it would be desirable to have less invasive methods anddevices for modifying target tissue in a spine to help ameliorate ortreat spinal stenosis, while inhibiting unwanted damage to non-targettissues. Ideally, such techniques and devices would reduce neural and/orneurovascular impingement without removing significant amounts ofvertebral bone, joint, or other spinal support structures, therebyavoiding the need for spinal fusion and, ideally, reducing the long-termmorbidity resulting from currently available surgical treatments. It mayalso be advantageous to have minimally invasive or less invasive tissuemodification devices capable of treating target tissues in parts of thebody other than the spine. At least some of these objectives will be metby the present invention.

SUMMARY OF THE INVENTION

In various embodiments, devices, systems and methods of the presentinvention provide minimally invasive or less invasive modification oftissue in a patient. For the purposes of this application, the phrase“tissue modification” includes any type of tissue modification, such asbut not limited to removing, cutting, shaving, abrading, shrinking,ablating, shredding, sanding, filing, contouring, carving, melting,heating, cooling, desiccating, expanding, moving, delivering medicationor other substance(s) to tissue and/or delivering an implantable device(such as a stent) to tissue.

In one aspect of the present invention, a device for removing tissuefrom a patient may include: an elongate flexible body having a proximalend, a distal end, and a longitudinal axis therebetween, the elongatebody having opposed first and second major surfaces with a lateralorientation across the axis; and a plurality of blades distributedlaterally across the first major surface. Each blade may have a firstend adjacent the first surface and extending to a cantilevered secondend, a first edge between the first and second ends of the blade beingoriented toward the distal end of the elongate body, a second edgebetween the first and second ends of the blade being oriented toward theproximal end of the elongate body, a height of the blade between itsfirst and second ends, and an axial length of the blade between itsfirst and second edges. The first edge and/or the second edge maycomprise a cutting edge so as to axially cut the ligament when the firstsurface is urged toward the ligament and the elongate body advancesalong a path toward one end of the elongate body. Both the height andthe axial length of each blade may be greater than a transverse width ofthe blade.

In some embodiments, each blade of the device may have an associatedbase extending along and affixed to the first surface with an angle orbend therebetween. Additionally, in some embodiments, at least some ofthe bases may be disposed laterally between a first associated blade anda second associated blade. In some embodiments, both the first edge andthe second edge of each blade may comprise a cutting edge so as toaxially cut the ligament and effect removal of the ligament when theelongate body reciprocates along the path.

In one embodiment, the tissue may comprise ligament tissue disposed overa curved bone surface, the second ends of at least some of the bladesmay comprise bone-cutting tips and extend to a distal bone-engagementheight from the first surface, and tension forces appliable manually tothe proximal and distal ends of the elongate body may urge the bonecutting tips through the ligament and into the bone when the firstsurface bends over the ligament tissue and the elongate body isreciprocated axially. In some embodiments, the first surface, whenbending over the bone surface, may have an active region with bladesthat can be urged into the ligament, and the manual tension forcesdivided by a combined surface area of the bone cutting tips within theactive region may be at least about 30,000 psi.

In an alternative embodiment, the tissue may comprise ligament tissuedisposed over a curved bone surface, the second ends of at least some ofthe blades may comprise bone-protecting surfaces and extend to a boneprotecting height from the first surface, and tension forces appliablemanually to the proximal and distal ends of the elongate body may resultin sliding of the bone-protecting surfaces along the bone surface so asto inhibit removal of the bone when the first surface bends over theligament tissue and the elongate body is reciprocated axially.

In another alternative embodiment, the tissue may comprise ligamenttissue disposed over a curved bone surface, the second ends of at leastsome of the blades may comprise bone-contacting edges and extend to abone-contacting height from the first surface, a first amount of tensionforce appliable manually to the proximal and distal ends of the elongatebody may result in sliding of the bone-contacting edges along the bonesurface so as to inhibit removal of the bone when the first surfacebends over the ligament tissue and the elongate body is reciprocatedaxially, and a second amount of tension force appliable manually to theproximal and distal ends of the elongate body may cause thebone-contacting edges to cut bone when the first surface bends over theligament tissue and the elongate body is reciprocated axially.

In some embodiments, a frontal surface area of the first or second edgeof each blade may be less than a side surface area of each blade. Insome embodiments, a side of each blade between its two edges may form anangle with the first surface of the elongate body of between about 45degrees and about 90 degrees, and the side of each blade may be alignedat an angle of between about 0 degrees and about 45 degrees relative tothe longitudinal axis of the elongate body. Even more preferably, insome embodiments, the side of each blade may form an angle with thefirst surface of between about 60 degrees and about 90 degrees, and theside of each blade may be aligned at an angle of between about 0 degreesand about 30 degrees relative to the longitudinal axis of the elongatebody. In some embodiments, at least two blades may be aligned atdifferent angles relative to the longitudinal axis of the elongate body.

In some embodiments, the elongate body may be configured to bend over acurved surface. In some embodiments, at least some of the blades may beaxially offset from one another along the longitudinal axis of theelongate body.

In some embodiments, the device may be configured to modify spinaltissue, and the elongate body may be configured to extend into thepatient's body, along a curved path through an intervertebral foramen ofthe spine, and out of the patient's body, such that a flexible portionof the elongate body of the device extends through the intervertebralforamen. In some embodiments, a height of each blade may be at leastequal to a thickness of a ligamentum flavum of the spine.

In some embodiments, the elongate body may include a rigid shaft, aflexible portion extending from one end of the shaft, a guidewirecoupler on or in the flexible portion, and a first handle coupled withan end of the shaft opposite the flexible portion. Optionally, thedevice may further include a guidewire configured to couple with theguidewire coupler and a second handle configured to couple with theguidewire outside the patient.

In various alternative embodiments, the second end of each blade mayhave a shape such as but not limited to a pointed tip, a flat edge, around edge, a serrated edge, a saw-toothed edge or a curved edge. Insome embodiments, second ends of at least two blades may have differentshapes, relative to one another. In some embodiments, at least twoblades may have different heights, relative to one another. In someembodiments, the blades may be fixedly attached to the first majorsurface.

In another aspect of the present invention, a device for removing tissuefrom a patient may include an elongate flexible body having a proximalend, a distal end, and a longitudinal axis therebetween, the elongatebody having opposed first and second major surfaces with a lateralorientation across the axis and a plurality of blades distributedlaterally across the first major surface, each blade having a first endadjacent the first surface and extending to a cantilevered second end.Each blade may substantially in-line with the longitudinal axis of theelongate body. Additionally, each blade may be substantially verticalrelative to the first surface. By “substantially in-line,” it is meantthat a side of each blade is aligned at an angle of between about 0degrees and about 45 degrees relative to the longitudinal axis of theelongate body. By “substantially vertical,” it is meant that each bladeforms an angle with the first surface of the elongate body of betweenabout 45 degrees and about 90 degrees. In some preferred embodiments,the side of each blade may be aligned at an angle of between about 0degrees and about 30 degrees relative to the longitudinal axis of theelongate body, and the side of each blade may form an angle with thefirst surface of between about 60 degrees and about 90 degrees.

In another aspect of the present invention, a method for removing targettissue from a patient may involve advancing an elongate flexible bodyalong a path between the target tissue and a non-target tissue, theflexible body having a plurality of laterally offset, cantileveredblades extending therefrom, and advancing the blades through the targettissue by moving the elongate body axially along the path so as to formlaterally offset cuts in the target tissue. In some embodiments, thetarget tissue may comprise ligament tissue disposed over bone, advancingthe elongate body may involve advancing along a curved path, and themethod may further involve applying pulling force at or near oppositeends of the elongate body to urge the laterally offset blades into theligament tissue, such that at least one of the blades contacts the bonebeneath the ligament.

In some embodiments, advancing the blades involves reciprocating theelongate body along the curved path. Some embodiments may furtherinvolve reciprocating the elongate body to remove a portion of the bone.In some embodiments, the elongate body may be advanced into anintervertebral foramen of the patient's spine, the target ligamenttissue may comprise ligamentum flavum, and the non-target tissue maycomprise neural tissue. Optionally, such a method may further includesteering the elongate body sideways within the intervertebral foramenduring the advancing step. In some embodiments, at least some of theblades may be angled relative to the longitudinal axis of the elongatebody, and advancing the blades through the target tissue may causecantilevered ends of the blades to ride along the bone to cause theelongate body to move sideways within the intervertebral foramen.

In some embodiments, the elongate body may be advanced percutaneouslyinto the patient by pulling the device behind a guidewire. Someembodiments may further involve inhibiting damage to the non-targettissue with an atraumatic surface of the elongate body configured tocontact the non-target tissue when the blades contact target tissue.Some embodiments of the method may further involve collecting cut tissuebetween at least some of the blades.

In another aspect of the present invention, a method for removingligamentum flavum tissue in a spine of a patient to treat spinalstenosis may involve: advancing a flexible elongate body of a tissuemodification device along a curved path through an intervertebralforamen in the spine, between ligamentum flavum and neural tissue;applying pulling force at or near opposite ends of the elongate body toadvance at least one cantilevered, laterally offset blade coupled with afirst major surface of the elongate body through the ligamentum flavumto contact vertebral bone, wherein each blade is substantially in-linewith a longitudinal axis of the elongate body, and wherein each blade issubstantially vertical relative to a the first major surface; andreciprocating the elongate body to remove ligamentum flavum tissue,wherein reciprocating the device while applying the force causes atleast one of the blades to ride along the bone and move the elongatebody laterally in the intervertebral foramen, relative to thelongitudinal axis of the elongate body. In some embodiments, the methodmay further involve inhibiting damage to the neural tissue with anatruamatic second major surface of the elongate body opposite the firstmajor surface.

These and other aspects and embodiments are described more fully belowin the Detailed Description, with reference to the attached Drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a vertebra with the cauda equina shown in crosssection and two nerve roots branching from the cauda equina to exit thecentral spinal canal and extend through intervertebral foramina oneither side of the vertebra;

FIG. 2A is a cross-sectional view of a patient's back and a side view ofa flexible tissue modification device in position in a spine, accordingto one embodiment of the present invention;

FIG. 2B is a diagrammatic view of a generic portion of a patient's body,showing target and non-target tissue, with the device of FIG. 2A inposition to modify target tissue, according to one embodiment of thepresent invention;

FIG. 2C is a side view of a tissue modification device, according to analternative embodiment of the present invention;

FIG. 2D is a side view of a tissue modification device, according toanother alternative embodiment of the present invention;

FIG. 3A is a view of a kit or system for modifying tissue, according toone embodiment of the present invention;

FIG. 3B is a side view of a portion of the kit of FIG. 3B;

FIGS. 4A-4E demonstrate a method for inserting and using a flexibletissue modification device to modify tissue while inhibiting damage tonon-target tissue, according to one embodiment of the present invention;

FIG. 5A is a perspective view of a flexible portion of a tissuemodification device, according to one embodiment of the presentinvention;

FIGS. 5B and 5C are end-on and side views of blade and substrateportions of the portion of the device of FIG. 5A;

FIG. 6 is a perspective view of a portion of a flexible substrate and awire saw tissue modifying member of a tissue modification device,according to one embodiment of the present invention;

FIG. 7 is a perspective view of a portion of a flexible substrate andmultiple wire saw tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 8 is a perspective view of a portion of a flexible substrate and anabrasive surface tissue modifying member of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 9 is a perspective view of a portion of a flexible substrate andmultiple tooth-like tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 10 is a perspective view of a portion of a flexible substrate and atwo-blade tissue modifying member of a tissue modification device,according to an alternative embodiment of the present invention;

FIG. 11 is a perspective view of a portion of a flexible substrate andmultiple shark-tooth-shaped tissue modifying members of a tissuemodification device, according to an alternative embodiment of thepresent invention;

FIG. 12 is a perspective view of a portion of a flexible substrate andmultiple cheese-grater-shaped tissue modifying members of a tissuemodification device, according to an alternative embodiment of thepresent invention;

FIG. 13 is a perspective view of a portion of a flexible substrate andmultiple raised tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 14 is a perspective view of a portion of a flexible substrate andmultiple raised-flap tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 15 is a perspective view of a portion of a flexible substrate andmultiple rounded tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 16 is a perspective view of a portion of a flexible substrate andmultiple raised-flap tissue modifying members of a tissue modificationdevice, according to an alternative embodiment of the present invention;

FIG. 17 is a perspective view of a portion of a flexible substrate andmultiple, differently shaped tissue modifying members of a tissuemodification device, according to an alternative embodiment of thepresent invention;

FIG. 18 is a perspective view of a portion of a flexible substrate andbarbed-hook and raised-flap tissue modifying members of a tissuemodification device, according to an alternative embodiment of thepresent invention;

FIG. 19 is a perspective view of a portion of a wire mesh flexibletissue modification device, according to an alternative embodiment ofthe present invention;

FIG. 20 is a perspective view of a portion of a flattened, hollow,flexible tissue modification device, according to an alternativeembodiment of the present invention;

FIG. 21 is a perspective view of a portion of a flexible substrate andcheese-grater-shaped tissue modifying members coupled with a tissuecapture member of a tissue modification device, according to analternative embodiment of the present invention;

FIG. 22 is a perspective view of a portion of a moveable-link flexibletissue modification device, according to an alternative embodiment ofthe present invention;

FIG. 23 is a side view of a tissue modification device in a position forperforming a tissue modification procedure, showing a generic bone, softtissue and non-target tissue, according to one embodiment of the presentinvention;

FIG. 24 is a side view of a tissue modification device with verticallyoriented blades, according to one embodiment of the present invention;

FIG. 25 is a perspective view of a flexible portion of a tissuemodification device with vertically oriented blades, according to oneembodiment of the present invention;

FIG. 26 is a top view of a flexible portion of a tissue modificationdevice with vertically oriented blades, according to one embodiment ofthe present invention;

FIGS. 27A-27D are end-on views of flexible portions of various tissuemodification devices with vertically oriented blades, according tovarious alternative embodiments of the present invention;

FIG. 28 is a top view of a flexible portion of a tissue modificationdevice with vertically oriented blades, according to an alternativeembodiment of the present invention;

FIGS. 29A-29E are end-on views of a flexible portion of a tissuemodification device with vertically oriented blades, demonstrating amethod for moving the device back and forth laterally in anintervertebral foramen, according to one embodiment of the presentinvention;

FIG. 30 is a perspective view of a double-blade member for attachment toa flexible portion of a tissue modification device, according to oneembodiment of the present invention;

FIG. 31 is a perspective view of a double-blade member for attachment toa flexible portion of a tissue modification device, according to analternative embodiment of the present invention;

FIG. 32 is a perspective view of a twelve-blade member for attachment toa flexible portion of a tissue modification device, according to analternative embodiment of the present invention;

FIG. 33 is a perspective view of a eight-blade member for attachment toa flexible portion of a tissue modification device, according to analternative embodiment of the present invention;

FIG. 34 is a side view of a flexible portion of a tissue modificationdevice with vertically oriented blades, according to one embodiment ofthe present invention;

FIG. 35 is a perspective view of a flexible portion of a tissuemodification device with vertically oriented blades, according to analternative embodiment of the present invention;

FIG. 36 is a top view of a flexible portion of a tissue modificationdevice, demonstrating a method for forming vertically oriented blades,according to an alternative embodiment of the present invention;

FIGS. 37-54 are side views of various configurations of blades for usewith tissue modification devices, according to various alternativeembodiments of the present invention; and

FIGS. 55-60 are cross-sectional views of various configurations ofblades for use with tissue modification devices, according to variousalternative embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments of tissue modification devices and systems, as wellas methods for making and using same, are provided. Although much of thefollowing description and accompanying drawing figures generally focuseson surgical procedures in spine, in alternative embodiments, devices,systems and methods of the present invention may be used in any of anumber of other anatomical locations in a patient's body. For example,in some embodiments, flexible tissue modification devices of the presentinvention may be used in minimally invasive procedures in the shoulder,elbow, wrist, hand, hip, knee, foot, ankle, other joints, or otheranatomical locations in the body. Similarly, although some embodimentsmay be used to remove or otherwise modify ligamentum flavum and/or bonein a spine to treat spinal stenosis, in alternative embodiments, any ofa number of other tissues may be modified to treat any of a number ofother conditions. For example, in various embodiments, treated tissuesmay include but are not limited to ligament, tendon, bone, tumor, cyst,cartilage, scar, osteophyte, inflammatory tissue and the like.Non-target tissues may include neural tissue and/or neurovascular tissuein some embodiments or any of a number of other tissues and/orstructures in other embodiments. In one alternative embodiment, forexample, a flexible tissue modification device may be used to incise atransverse carpal ligament in a wrist while inhibiting damage to themedian nerve, to perform a minimally invasive carpal tunnel releaseprocedure. Thus, various embodiments described herein may be used tomodify any of a number of different tissues, in any of a number ofanatomical locations in the body, to treat any of a number of differentconditions.

With reference now to FIG. 2A, a tissue modification device 10 accordingto one embodiment may suitably include a proximal handle 20 coupled witha shaft 12 having a proximal, rigid portion 13 and a distal, flexibleportion 14 on which one or more tissue modifying members 16 may bedisposed. A guidewire coupler 18 may be formed in (or attached to)flexible portion 14 at or near its distal end, for coupling with aguidewire 22, which in turn may be coupled with a guidewire handle 24(or “distal handle”), which may include a tightening lever 25 fortightening handle 24 around guidewire 22.

Device 10 is shown percutaneously placed in position for performing atissue modification procedure in a patient's spine, with variousanatomical structures shown including a vertebra V, cauda equina CE,ligamentum flavum LF, nerve root NR, facet F, and intervertebral foramenIF. Various embodiments of device 10 may be used in the spine to removeligamentum flavum LF, facet bone F, bony growths, or some combinationthereof, to help decompress cauda equina CE and/or nerve root NR tissueand thus help treat spinal stenosis and/or neural or neurovascularimpingement. Although this use of device 10 will not be continuouslyrepeated for every embodiment below, any of the described embodimentsmay be used to remove ligamentum flavum alone, bone alone, or acombination of ligament and bone in the spine to treat neuralimpingement, neurovascular impingement and/or spinal stenosis.

In one embodiment of a method for modifying tissue using device 10, adistal end of 22 guidewire may be placed into the patient, along acurved path between target and non-target tissue, and out of thepatient. A distal portion of guidewire 22 may then be coupled withguidewire handle 24, such as by passing guidewire 22 through a centralbore in handle 24 and tightening handle 24 around guidewire 22 viatightening lever 25 or other tightening means. A proximal end ofguidewire 22 may then be coupled with coupling member 18 and used topull distal shaft portion 14 between target and non-target tissues. Insome embodiments, device 10 may be advanced into the patientpercutaneously, while in alternative embodiments, device 10 may beadvanced through a small incision or larger incision. Once advanced intothe patient, flexible distal shaft portion 14 may be advanced along acurved path between the target and non-target tissues, and in someinstances may be pulled at least partway into an intervertebral foramenIF of the spine.

Proximal handle 20 and guidewire handle 24 may be pulled (or“tensioned”—solid/single-tipped arrows) to urge tissue modifying members16 against the target tissue (in this case, ligamentum flavum LF).Generally, tissue modifying members 16 may be fixedly attached to (orformed in) one side or surface of distal portion 14, while an oppositeside or portion of distal portion 14 faces non-target tissue, such ascauda equina CE and/or nerve root NR. The opposite side of distalportion 14 will generally be atraumatic and/or include an atraumaticcover, coating, shield, barrier, tissue capture member or the like. Withtensioning force applied to device 10, handles 20, 24 may be used toreciprocate device 10 back and forth (solid/double-tipped arrows) tocause tissue modifying members 16 to cut, remove, shred or otherwisemodify the target tissue. In various embodiments, for example, targettissue may include only ligamentum flavum LF, only bone, or acombination of both.

Reciprocation and tensioning may be continued until a desired amount oftissue is removed. Removed target tissue, in some embodiments, may becollected, captured or trapped between tissue modifying members 16and/or in one or more tissue capture members or chambers (not shown).When a desired amount of target tissue has been removed, which may bedetermined, for example, by tactile feedback provided to the surgeon bydevice 10, by radiographic imaging, and/or by direct visualization (suchas in an open surgical case), guidewire 22 may be released from distalhandle 24, and device 10 may be removed from the patient's back. Ifdesired, device 10 may be passed into the patient's spine again foradditional tissue modification, and/or other devices may be passed intothe spine.

Additional details of various methods for inserting and using device 10are provided below. For further explanation of guidewire systems andmethods for inserting devices to remove or otherwise modify tissue,reference may also be made to U.S. patent application Ser. No.11/468,247 (now U.S. Pat. No. 7,857,813) and Ser. No. 11/468,252(Publication No. US-2008-0086034-A1), both titled “Tissue AccessGuidewire System and Method,” and both filed Aug. 29, 2006, the fulldisclosures of which are herein incorporated by reference in theirentirety.

Referring now to FIG. 2B, in various embodiments, device 10 may be usedin parts of the body other than spine to remove target tissue TT whileavoiding harm to non-target tissue NTT. For example, target tissue TTmay include soft tissue adhering to bone, such as ligament and/orcartilage, and/or may include bone. Non-target tissue NTT may includeany nervous tissue, vascular tissue, an organ, or any other tissue thata surgeon may desire to leave unharmed by a surgical procedure. In oneembodiment, for example, device 10 may be used to perform a minimallyinvasive carpal tunnel release procedure by releasing the transversecarpal ligament without damaging the median nerve. In some embodiments,such a procedure may be performed percutaneously with or without anendoscope. In other embodiments, device 10 may be used to removecartilage and/or ligament from a knee or shoulder in a minimallyinvasive procedure. In yet another embodiment, device 10 may be used toperform a minimally invasive bunionectomy. Therefore, although thefollowing discussion focuses primarily on various uses of alternativeembodiments of device 10 in spine, any of a number of other anatomicalstructures may be operated upon in different embodiments.

Referring now to FIG. 2C, in an alternative embodiment, a tissuemodification device 10′ may suitably include a proximal handle 20′,including a squeeze actuator 21′ and coupled with a shaft 12′ having aproximal, rigid portion 13′ and a distal, flexible portion 14′. One ormore tissue modifying members 16′ may be moveably coupled with one sideof flexible portion 14′, and a guidewire coupler 18′ may be formed in(or attached to) flexible portion 14′ at or near its distal end, forcoupling with a guidewire 22′ and thus a distal handle 24′ with atightening lever 25′.

In this alternative embodiment, squeeze actuator 21′ may be coupled withmoveable tissue modifying members 16′ by any suitable means, such thatactuating actuator 21′ (double-headed, solid-tipped arrow) causes tissuemodifying members 16′ to reciprocate back and forth (double-headed,hollow-tipped arrow). In use, therefore, device 10′ as a whole may beheld relatively stationary, while tissue modifying members 16′ arereciprocated. Proximal handle 20′ and rigid proximal shaft portion 13′may be used to steer device 10′ relative to target tissue, and of coursedevice 10′ may be moved in and out of the patient and/or the targettissue, but it may also be possible to hold device 10′ relativelystationary while reciprocating tissue modifying members 16′. In variousembodiments, squeeze actuator 21′ may be replaced with any suitablemechanical actuator, such as a trigger, lever or the like.

With reference now to FIG. 2D, in another alternative embodiment, atissue modification device 10″ may be similar to the previous embodimentbut may include, instead of squeeze actuator 21′, a button actuator 21″and a powered drive mechanism within handle 20″. Pressing buttonactuator 21″ may activate tissue modifying members 16″ to reciprocateback and forth to modify tissue. In various alternative embodiments,button 21″ may be replaced with any suitable actuator, such as atrigger, switch, dial or the like.

With reference now to FIG. 3A, in some embodiments tissue modificationdevice 10 may be provided as a system (or “kit”), including the variouscomponents described above in reference to FIGS. 2A and 2B. In someembodiments, a tissue modification system 15 or kit may suitably includedevice 10 of FIGS. 2A and 2B, as well as one or more additional devicesor components. For example, multiple guidewires 22 may be provided aspart of system 15. In some embodiments, system 15 may also include oneor more guidewire passage probes 32, 34 and a curved, flexible guidemember 36. In one embodiment, for example, an ipsilateral access probe32 and a contralateral access probe 34 may be provided. Curved guidemember 36 is generally configured to pass through a lumen in each ofprobes 32, 34 and includes an inner lumen through which guidewire 22 maybe passed. Guide member 36 may further include one or more depth marks35 to indicate to a surgeon when guide member 36 has been passed acertain distance into probe 32, 34 and a stop 37 to limit passage ofguide member 36 farther into probe 32, 34. In an alternative embodiment(not shown), such as might be used in a completely percutaneousprocedure, probes 32, 34 may be replaced with an introducer needle, suchas but not limited to a 14 gauge Touhy epidural needle or other size ortype of epidural needle. In such an embodiment, guide member 36 may bedesigned to pass through the bore of the needle. For further descriptionof various probe and guide member devices, reference may be made to U.S.patent application Ser. No. 11/468,247 (now U.S. Pat. No. 7,857,813) andSer. No. 11/468,252 (Publication No. US-2008-0086034-A1). Furtherreference may be made to U.S. patent application Ser. No. 11/457,416,titled “Spinal Access and Neural Localization,” and filed Jul. 13, 2006,now U.S. Pat. No. 7,578,819; and Ser. No. 60/823,594, titled “SurgicalProbe and Method of Making,” and filed Aug. 25, 2006, the fulldisclosures of which are herein incorporated by reference in theirentirety.

Guidewire 22 may be made of any suitable material, such as nitinol orstainless steel, and may include a sharp distal tip 23, to facilitatepassage of guidewire 22 through tissue, and a proximal shaped end 27 forcoupling with guidewire coupler 18. Further details of various guidewire22 embodiments and distal handle 24 are provided, for example, in U.S.patent application Ser. No. 11/468,247 (now U.S. Pat. No. 7,857,813) andSer. No. 11/468,252 (Publication No. US-2008-0086034-A1), which werepreviously incorporated by reference.

FIGS. 3A and 3B show proximal handle 20 and shaft 12 in greater detailthan in previous figures. In the embodiment shown, four tissue modifyingmembers 16 are fixedly attached to one side of flexible distal shaftportion 14, each comprising grooved blades with bi-directional cuttingedges. In various alternative embodiments, any number of tissuemodifying members 16 may be included, such as from one to twenty tissuemodifying members 16. Furthermore, tissue modifying members 16 may haveany of a number of different configurations, some of which are describedbelow, such uni-directional blades, bi-directional blades, teeth, hooks,barbs, hooks, pieces of Gigli saw (or other wire saw), wires, meshes,woven material, knitted material, braided material, planes, graters,raised bumps, other abrasive surfaces, other abrasive materials,deliverable substances and/or the like.

In various embodiments, proximal shaft portion 13, distal shaft portion14, tissue modifying members 16 and guidewire coupler 18 may be made ofany suitable material (or materials), and may be made from one piece ofmaterial as a single extrusion or from separate pieces attachedtogether. For example, in many embodiments, all of shaft 12 andguidewire coupler 18 may be made from one piece of material, and tissuemodifying members 16 may be attached to distal shaft portion 14, such asby welding. In alternative embodiments, however, guidewire coupler 18may be a separate piece attached to distal shaft portion 14 and/ortissue modifying members 16 may be formed in (rather than attached to)distal shaft portion 14. In yet another embodiment, distal shaft portion14 may comprise a flat piece of material coupled with rigid proximalshaft portion 13, such as by welding. In some embodiments, shaft 12 maybe formed from one piece of material, and distal shaft portion 14 may beflattened to derive its shape and flexibility. In some embodiments, oneor more slits may be formed in distal shaft portion 14, to enhance itsflexibility. In some embodiments, proximal shaft portion 13 may have acylindrical shape. In some embodiments proximal shaft portion 13, distalshaft portion 14, or both may be hollow. Alternatively, any portion ofshaft 12 may be solid in some embodiments, such as to give proximalshaft portion 13 added rigidity.

In one embodiment, guidewire coupler 18 may include a slot 19, shaped toreceive and hold guidewire proximal shaped end 27. In variousembodiments, slot 19 may be located on the top surface of distal shaftportion 14, as shown, or on the bottom surface. For further descriptionof various embodiments of guidewire couplers, reference may be made toU.S. patent application Ser. Nos. 11/468,247 and 11/468,252. In someembodiments, an atraumatic cover 30 may be disposed over part of distalshaft portion 14, forming atraumatic edges 33 and an aperture 31 throughwhich tissue modifying members 16 protrude. Cover 30 may be made of anysuitable atraumatic material, such as any of a number of differentpolymers. In some embodiments, cover 30 may also serve to collect cuttissue. Cover 30 may be made of any suitable material, such as apolymer, examples of which are provided below. In some embodiments,cover 30 may be made from a porous or semi-permeable material and/or oneor multiple holes may be formed in cover 30 to allow fluid to passthrough cover 30, thus allowing a greater amount of solid material to bepacked into a tissue collection portion of cover 30.

FIG. 3B is a side view of device 10. Tissue modifying members 16 may beseen extending above atraumatic edges 33 of cover 30 and having cuttingedges facing both proximally and distally. In alternative embodiments,tissue modifying members 16 may have only uni-directional cutting edges,such as facing only proximally or only distally. In the embodimentshown, guidewire coupler 18 is formed as a loop at the distal end ofdistal shaft portion 14. Guidewire shaped end 27 may generally fit intoslot 19 (not visible in FIG. 3B) to reside within the loop of guidewirecoupler 18 during use. In other embodiments, guidewire coupler 18 maycomprise a separate piece attached to the top side or bottom side ofdistal shaft portion 14. Examples of such embodiments are describedfurther in U.S. patent application Ser. No. 11/468,247 (now U.S. Pat.No. 7,857,813) and Ser. No. 11/468,252 (Publication No.US-2008-0086034-A1).

The various components of device 10, including proximal handle 20, shaft12, tissue modifying members 16, guidewire coupler 18, and cover 30, maybe fabricated from any suitable material or combination of materials.Suitable materials include, for example, metals, polymers, ceramics, orcomposites thereof. Suitable metals may include, but are not limited to,stainless steel (303, 304, 316, 316 L), nickel-titanium alloy, tungstencarbide alloy, or cobalt-chromium alloy, for example, Elgiloy® (ElginSpecialty Metals, Elgin, Ill., USA), Conichrome® (Carpenter Technology,Reading, Pa., USA), or Phynox® (Imphy SA, Paris, France). Suitablepolymers include, but are not limited to, nylon, polyester, Dacron®,polyethylene, acetal, Delrin® (DuPont, Wilmington, Del.), polycarbonate,nylon, polyetheretherketone (PEEK), and polyetherketoneketone (PEKK).Ceramics may include, but are not limited to, aluminas, zirconias, andcarbides. In some embodiments, one or more portions of shaft 12, forexample, may be reinforced with carbon fiber, fiberglass or the like.

Referring now to FIGS. 4A-4E, one embodiment of a method for modifyingtissue using flexible tissue modification device 10 is demonstrated ingreater detail. In these figures, a patient's skin, target tissue TT andnon-target tissue NTT are shown diagrammatically, rather than asspecific structures. In one embodiment, the method of FIGS. 4A-4E may beemployed in the spine, to remove ligamentum flavum, bone or both, withdevice 10 passing through an intervertebral foramen between twovertebrae, as shown in FIG. 2A. In other embodiments, other tissue inother areas of the body may be removed.

As shown in FIG. 4A, guidewire 22 with sharp tip 23 and shaped end 27may be passed into the skin, between target and non-target tissue, andout of the skin. Methods for passing guidewire 22 are described further,for example, in U.S. patent application Ser. No. 11/457,416 (now U.S.Pat. No. 7,578,819), Ser. No. 11/468,247 (now U.S. Pat. No. 7,857,813)and Ser. No. 11/468,252 (Publication No. US-2008-0086034-A1), which werepreviously incorporated by reference. As described in those references,in various embodiments, guidewire 22 may be placed using a percutaneousmethod, such as with a needle, or using an open method, such as with aprobe. In some embodiments, localization of neural tissue, such as withnerve stimulation on a guidewire passing probe or guidewire passingguide member may be used, to confirm that guidewire 22 is passed betweentarget and non-target tissue.

In some embodiments where the method is performed in the spine, one ormore substances or devices may be placed into the epidural space of thespine before or after placing guidewire 22, to create additional spacebetween target tissues, such as ligamentum flavum, and non-targettissues, such as cauda equina and nerve root. Substances may include,for example, any of a number of fluids or gels, such as radiographiccontrast medium. Devices may include, for example, a barrier or shielddevice. Injection of substances into the epidural space to create asafety zone is described in U.S. patent application Ser. No. 11/193,557(Publication No. 2006/0036211), titled “Spinal Ligament ModificationKit,” assigned to X-Sten, Inc., and filed Jul. 29, 2005, the fulldisclosure of which is hereby incorporated by reference. Various barrierdevices for placement in the spine are described, for example, in U.S.patent application Ser. No. 11/405,859, titled “Tissue ModificationBarrier Devices and Methods,” and filed Apr. 17, 2005, Publication No.US-2007-0213734-A1, the full disclosure of which is herein incorporatedby reference in its entirety.

Referring to FIG. 4B, distal handle 24 may be passed over sharp tip 23and tightened around guidewire 22, such as by moving tightening lever25. Distal handle 24 may be coupled with guidewire 22 at this point inthe process or at a later point, according to various embodiments.

As shown in FIG. 4C, guidewire 22 may next be coupled with proximaldevice portion 11, by coupling shaped guidewire end 27 (not visible)with guidewire coupler 18. In the embodiment shown, for example,guidewire shaped end 27 may be placed into coupling member 18(hollow-tipped arrow).

Referring to FIG. 4D, distal handle 24 may then be pulled (hollow-tippedarrow) to pull device 10 into the patient and to thus position tissuemodifying members 16 in contact with target tissue TT. In someembodiments, such as when device 10 is used in a spinal procedure andpasses through an intervertebral foramen, a surgeon or other physicianuser may use tactile feedback of device 10 passing into the foramen,such as when coupling member 18 and/or tissue modifying members 16 passinto the foramen, to determine when tissue modifying members 16 arepositioned in a desired location relative to target tissue TT.Alternatively or additionally, a surgeon may confirm that a desiredplacement has been achieved by using radiographic imaging, such asfluoroscopy, direct visualization, such as in an open surgical case, ora combination of multiple methods.

In some embodiments in which device 10 is used in the spine to treatspinal stenosis and/or neural or neurovascular impingement, device 10may be passed into the patient and to a position for modifying tissuewithout removing any vertebral bone. More specifically, in someembodiments, device 10 may be advanced into the patient, through anintervertebral foramen, and out of the patient without removing bone.This is contrary to the majority of current surgical methods fortreating spinal stenosis, which typically include removal of at leastsome vertebral bone, such as performing a laminotomy or laminectomy, andwhich often remove significant amounts of vertebral lamina, spinousprocess, facet and/or pedicle bony tissue, simply to access the surgicalsite. In one embodiment, for example, device 10 may be advancedpercutaneously into the patient, used to remove ligamentum flavum only,and withdrawn from the patient, without removing any vertebral bone.

As shown in FIG. 4E, once tissue modifying members 16 are positioned asdesired, relative to target tissue TT, proximal handle 20 and guidewirehandle 24 may be pulled (hollow-tipped arrows) to urge tissue modifyingmembers 16 against target tissue TT (solid-tipped, single-headedarrows). While maintaining pulling/tensioning force, handles 20, 24 maybe used to reciprocate device 10 back and forth (solid-tipped,double-headed arrows) to remove target tissue TT. During a procedure,rigid proximal shaft portion 13 may be used to help steer device 10, ormore specifically flexible distal shaft portion 14, relative to thetarget TT. For example, rigid shaft portion 13 may be used to moveflexible portion 14 laterally or to pivot shaft 12 about an axis locatedalong flexible portion 14. In one embodiment, for example, rigid portion13 may be used to manipulate flexible portion 14 within anintervertebral foramen, such as by pivoting shaft 12 or moving flexibleportion 14 laterally in a caudal and/or cephalad direction, relative tothe patient. The rigidity of rigid proximal shaft portion 13 maygenerally facilitate such steering, as compared to a completely flexibledevice.

When a desired amount of tissue is removed, device 10 may be removedfrom the patient, such as by detaching guidewire handle 24 fromguidewire 22 and pulling proximal handle 20 to withdraw device 10 andguidewire 22 out of the patient. In some embodiments, device 10 or anadditional device may be reinserted into the patient and used in asecond location to remove additional tissue. For example, in a spinalstenosis treatment procedure, device 10 may be used to remove tissuefrom (and thus decompress) a first intervertebral foramen and then maybe removed and reinserted to remove tissue from a second foramen. Thisprocess may be repeated to remove tissue from any number of foramina. Inone embodiment, device 10 may include a guidewire lumen, so that aguidewire may be placed into a second foramen while device 10 is in theepidural space of the patient. Device 10 may then be removed along withthe first guidewire 22, attached to the second guidewire, and reinsertedinto the second foramen to remove tissue. In some embodiments, tissuemay be removed from device 10 before reinserting device 10 into thepatient to remove more tissue.

Referring now to FIGS. 5A-5C, a flexible distal portion 40 of a flexibletissue modification device is shown, in various views. In FIGS. 5A-5Cand 6-25, various alternative embodiments of a flexible distal portionof a tissue modification device are shown in a generally straightconfiguration. However, all embodiments shown are flexible and thus mayassume a curved configuration. The embodiments are shown in straightconfiguration for ease of illustration only.

In one embodiment, flexible distal portion 40 may include a substrate 42(or “flexible, distal shaft portion”), multiple tissue modifying members44 coupled with substrate 42, and an atraumatic cover 46 disposed oversubstrate 42 and forming an aperture 48 and atraumatic bumpers 49. FIG.5B is an end-on view of substrate 42 and one of cutting members 44,which includes multiple teeth 45. FIG. 5C is a side view of substrate 42and one of cutting members 44, showing that each cutting member 44 hastwo cutting edges 43 in this embodiment.

The embodiment of FIG. 5A includes three cutting members 44 comprisingblades with multiple teeth 45 with grooves between them. Cutting members44 in this and other embodiments may include any suitable material, suchas but not limited to stainless steel or any of the materials listedpreviously above. Any number of cutting members 44 may be used, such asfrom one to twenty cutting members in various embodiments. Cuttingmembers 44 may have any suitable height and may be spaced apart from oneanother at any suitable distances. In one embodiment, for example,cutting members 44 may have a height designed to protrude just slightlyabove the height of bumpers 49, so that cutting members 44 can cuttissue but do not protrude so high as to inhibit advancement orpositioning of device in the patient. In some embodiments, cuttingmembers 44 may be constructed as separate pieces and attached tosubstrate 42, such as by welding or gluing with adhesive. In someembodiments, cutting members 44 may be built by stacking layers ofmaterial to one another and attaching the stacks to form one piece.Cover 46 may be coupled with substrate using any known or later inventedmanufacturing technique, such as thermoforming, injection molding or thelike.

In various alternative embodiments of distal portion 40 of FIGS. 5A-5C,as well as in all embodiments described below and alternatives thereto,any number of cutting members 44 may be used, cutting members 44 may bemade of any suitable material, and cutting members may be disposed alongsubstrate 42 in any configuration, pattern or the like. Therefore,various alternative materials, numbers, patterns and the like of cuttingmembers 44 will not be listed repeatedly for each alternativeembodiment.

Referring now to FIG. 6, in another embodiment, a distal portion of aflexible tissue modification device 50 may include substrate 42 and awire saw 52 coupled with substrate 42, such as by welding. In FIG. 6, aswell as in subsequent FIGS. 7-22, only a portion of each deviceembodiment including substrate 42 and one or more cutting members isshown, to simplify the drawing figures and description. Any of theseembodiments may also include an atraumatic cover and/or other features,but for simplicity's sake, these features are not shown. Referring tothe embodiment of FIG. 6, wire saw 52 may comprise any wire sawcurrently known or later invented, such as a Gigli saw, and may beattached to substrate 42 in any suitable pattern or configuration, suchas in an S-shape pattern, as shown, or a zig-zag, straight-line or otherpattern.

With reference to FIG. 7, in an alternative embodiment, a distal portionof a flexible tissue modification device 54 may include multiple piecesof wire saw 56 coupled with substrate 42. Again, these pieces of saw 56may be attached in any pattern and by any means, such as by welding, andmay comprise Gigli saw or other types of wire saw.

FIG. 8 shows a portion of another alternative embodiment of a flexibletissue modification device 58, in which abrasive materials 60, 62 areadhered to a surface of substrate. In some embodiments, only one typeand/or grain of abrasive material 60 or 62 may be used, while otherembodiments may include multiple types of material, multiple grains ofmaterial, or both. For example, in the embodiment shown, a finer grainof material 60 may be disposed at either end of a portion of coarsergrain material 62. Such a variation in grains may provide varyingdegrees of tissue modification and/or the ability to remove greateramounts of tissue with a coarser grain 62 and provide a smootherfinished surface to the tissue with the finer grain 60. In variousembodiments, any abrasive materials 60, 62 may be used, and thematerials may be adhered to substrate 42 via any method, such asadhering with adhesive or the like. One embodiment, for example, mayinclude abrasive materials such as those described in U.S. patentapplication Ser. No. 10/277,776 (Publication No. 2003/0225412), titled“Surgical Ribbon File,” and filed Oct. 21, 2002, the full disclosure ofwhich is hereby incorporated by reference. In another embodiment,substrate 42 may be treated in such a way as to have an abrasivesurface, such as by sand blasting.

Referring to FIG. 9, in another alternative embodiment, a flexibletissue modification device 64 may include multiple tissue modifyingmembers 66, each including multiple, curved teeth 68. Cutting members 66may be made of stainless steel or other material(s). In someembodiments, cutting members 66 may be configured to primarily cutand/or shred ligamentous tissue, such as ligamentum flavum.

Referring to FIG. 10, in another alternative embodiment, a flexibletissue modification device 70 may include one or more tissue modifyingmembers 72 coupled with a first major surface of a flexible substrate42. Each tissue modifying member 72 may include a base 73 disposedbetween two blades 74, with a bend between base 73 and each blade 74. Aswill be described in greater detail below, each blade 74 may have afirst end coupled with substrate 42 via base 73 and may extend to asecond, cantilevered end. In some embodiments, each blade 74 may besubstantially in-line (i.e., a side of blade 74 oriented at betweenabout 0 degrees and about 45 degrees relative to a longitudinal axis ofsubstrate 42) and may also be substantially vertical (i.e., a side ofblade 74 forms an angle with the plane of substrate 42 of between about45 degrees and about 90 degrees). Blades 74 may have any of a number ofshapes, heights, lengths and the like, a number of embodiments of whichwill be described below. For example, blades 74 may be designed, in oneembodiment, specifically for cutting or slicing ligamentous tissue, suchas ligamentum flavum.

Referring to FIG. 11, in another alternative embodiment, a flexibletissue modification device 76 may include multiple, laterally offsettissue modifying members 78 disposed laterally across a first majorsurface of a substrate flexible portion 42. In one embodiment, forexample, each tissue modifying member 78 may include a base 79 with twosubstantially vertical blades 80 disposed at its opposite ends. Anysuitable number of tissue modifying members 78 may be used in a givenembodiment, such as but not limited to between two members 78 (fourblades 78) and eight members 78 (16 blades 78), in alternativeembodiments. Blades 80 may each have a triangular or “shark-tooth”shape, with two sharp cutting edges and a pointed cantilevered tip. Inalternative embodiments, any of a number of other blade configurationsmay be used, some of which are described in greater detail below. In oneembodiment, blades 80 may be designed specifically for cutting orslicing ligamentous tissue, such as ligamentum flavum. Alternatively, oradditionally, blades 80 may be configured to cut bone. In oneembodiment, each blade 80 may have a height approximately equal to orgreater than a thickness of a ligamentum flavum. Such a blade 80 may bepositioned in the spine to extend through ligamentum flavum and contactbone. When reciprocated, such a blade 80 may cut ligamentum flavum aloneor may cut ligamentum flavum tissue and then, when it is removed, mayalso cut bone. Such a blade height and configuration may facilitatelateral steering of device 76. Various alternative embodiments of tissuemodification devices having vertically oriented blades are described ingreater detail below, with reference to FIGS. 23-60.

Referring to FIG. 12, in another alternative embodiment, a flexibletissue modification device 82 may include multiple tissue modifyingmembers 84 formed as holes in substrate 42 with raised edges, such asare found on a cheese grater. The raised edges of cutting members 84 maybe sharp, to provide cutting. Any number of tissue modifying members 84may be included, they may have any desired size, and they may be formedon substrate in any pattern. In some embodiments, cut tissue may passthrough the holes of cutting members 84 and thus through substrate 42.In some embodiments, a tissue capture device or member may be coupledwith the back side of substrate 42 to collect cut tissue that passesthrough cutting members 84.

Referring to FIG. 13, in another alternative embodiment, a flexibletissue modification device 86 may include multiple tissue modifyingmembers 88 formed as upward-facing holes in substrate 42. The raisededges of cutting members 88 may be sharpened, to provide cutting. Anynumber of tissue modifying members 88 may be included. In someembodiments, cut tissue may pass through the holes of cutting members 88and thus through substrate 42. In some embodiments, a tissue capturedevice or member may be coupled with the back side of substrate tocollect cut tissue that passes through cutting members 88.

Referring to FIG. 14, in another alternative embodiment, a flexibletissue modification device 90 may include multiple tissue modifyingmembers 92 formed as raised flaps in substrate 42, with each flap 92including a sharpened cutting edge 94. Any number of tissue modifyingmembers 92 may be included. In some embodiments, cut tissue may passunderneath the flap-like cutting members 92 and thus through substrate42. In some embodiments, a tissue capture device or member may becoupled with the back side of substrate to collect cut tissue thatpasses through cutting members 92.

Referring to FIG. 15, in another alternative embodiment, a flexibletissue modification device 96 may include multiple tissue modifyingmembers 98 formed as rounded cutting devices coupled with substrate 42.In one embodiment, each cutting member 98 may include multiple ridges,divided by grooves. In one embodiment, cutting members 98 may have aspiral or screw-like configuration.

Referring to FIG. 16, in another alternative embodiment, a flexibletissue modification device 102 may include multiple tissue modifyingmembers 104 comprising thin, flap-like blades coupled with substrate 42,each cutting member 104 including a sharp blade edge 106. Any number,size and configuration of blades may be used.

Referring to FIG. 17, in another alternative embodiment, a flexibletissue modification device 108 may include multiple different types oftissue modifying members 110, 111. For example, one embodiment mayinclude one or more jagged tissue cutters 110 each having multiple,triangular, raised teeth 112, and one or more bladed tissue cutters 111,each having multiple blades 113. Teeth 112 and/or blades 113 may beconfigured specifically to cut ligamentum flavum tissue, bone, or both,in various embodiments.

Referring to FIG. 18, in another alternative embodiment, a flexibletissue modification device 114 may include substrate 42, a tissueengaging member 116 including multiple barbs 117 (or hooks, needles orthe like), and one or more tissue cutting members 118, such as a raisedblade. In various embodiments, tissue engaging member 116 may beconfigured to hook, snag, grab or otherwise engage soft tissue, such asligamentum flavum, and pull or stretch such tissue as it is pulled orpushed across the tissue. Tissue cutting member 118 may follow behindtissue engaging member 116 and cut the stretched/pulled tissue. Suchstretching or pulling of tissue before cutting may facilitate or enhancetissue cutting.

Referring to FIG. 19, in another alternative embodiment, a flexibletissue modification device 122 may include a wire mesh 124 coupled withmultiple supporting structures 126 and an atraumatic material 128 on oneside. All components may be made of any suitable material, such as thoselisted previously.

Referring to FIG. 20, in another alternative embodiment, a flexibletissue modification device 130 may comprise a hollow, flattened shaft132, having central chamber or lumen 134, into which multiple grooves136 may be cut. An edge of each groove 136 may be raised and sharpenedto form a blade edge 138, thus forming a multiple, bladed tissuemodifying members. Tissue cut by blades 138 may pass under blades 138 tocollect within lumen 134 and may thus be transported out of the patient.

Referring to FIG. 21, in another alternative embodiment, a flexibletissue modification device 140 may include multiple tissue modifyingmembers 142 formed as holes in substrate 42 with raised edges, such asare found on a cheese grater. The raised edges of cutting members 142may be sharpened, to provide cutting. Any number of tissue modifyingmembers 142 may be included. In some embodiments, cut tissue may passthrough the holes of cutting members 142 and thus through substrate 42.In some embodiments, a tissue collection member 144, forming a tissuecollection chamber 148, may be coupled with the back side of substrate42 to collect cut tissue that passes through cutting members 142. Tissuecollection member 144 may also serve as an atraumatic tissue protectionmember and may include, for example, side bumpers 146 to avoid damagingnon-target tissue with sharp edges of device 140. In some embodiments,tissue collection member 144 may be strengthened by multiple fibers 145,such as wires or carbon fibers.

Referring to FIG. 22, in another alternative embodiment, a flexibletissue modification device 150 may include multiple sections 152 linkedtogether via linkages 154 to form a flexible device configurationanalogous to that of some watch bands. A tissue modifying member 156having a cutting edge 158 may be disposed on one side of each section152 to cut tissue.

With reference now to FIG. 23, in another alternative embodiment, atissue modification device 160 may suitably include a proximal handle170 coupled with an elongate body 162 (or “shaft”) having a proximal,rigid shaft portion 163, a distal flexible portion 164 having a firstmajor surface 165 and an opposed second major surface 167, and multiplesubstantially in-line, substantially vertical blades 166 disposedlaterally across first major surface 165. Second major surface 167 maybe atraumatic, to inhibit injury to non-target tissues NTT. A guidewirecoupler 168 may be formed in (or attached to) flexible portion 164 at ornear its distal end, for coupling with a guidewire 172, which in turnmay be coupled with a guidewire handle 174 (or “distal handle”), whichmay include a tightening lever 175 for tightening handle 174 aroundguidewire 172. In one embodiment, device 160 may have many of thecharacteristics and be used in much the same way as embodimentsdescribed above, such as device 10 of FIG. 2A. The number, height,length, configuration and placement of blades 166, however, may conferunique tissue cutting/removal characteristics to device 160.

In FIG. 23, device 160 is shown passing into a patient, along a curvedpath between a generic soft tissue/bone combination and nearbynon-target tissue NTT, and back out of the patient. In one embodiment,device 160 may be passed into a patient, through an intervertebral spaceof the patient's spine (between ligamentum flavum andneural/neurovascular tissue), and back out of the patient, as describedin detail above with reference to alternative embodiments. Once device160 is in place for modifying a target tissue, such as soft tissueand/or bone, handles 170, 174 may be pulled (hollow-tipped arrows) toapply force and thus urge blades 166 into soft tissue (single-headed,solid-tipped arrows). Device 160 may then be reciprocated(double-headed, solid-tipped arrows), while maintaining some or all ofthe pulling force, to remove or otherwise modify the target soft tissueand/or bone. As mentioned previously, before reciprocating device 160 toremove tissue, in some embodiments the device may be used to stimulatenearby nerve tissue, such as with an electrode coupled with second majorsurface 167 and/or first major surface 167. Such nerve stimulation mayhelp confirm that device 160 has been placed in a desired location fortreatment and may be monitored using electromyography (EMG), visualobservation of muscle twitch and/or the like. Second major surface 167may be made atraumatic in a number of different ways, such as but notlimited to forming second major surface 167 with an atraumatic material,smoothing surface 167 during the manufacturing process, coupling anatraumatic cover with surface 167 and/or coating surface 167 with alubricious coating.

In various embodiments, device 160 may be optimized for removal of softtissue (such as ligamentum flavum or other ligamentous tissue), bone ora combination of both. Such optimization, for example, may be achievedwith various heights, lengths, edge types, numbers and/or placement ofblades 166. In some embodiments, it may be possible to remove both softtissue and bone with device 160, such as by continuing to reciprocatedevice 160 after soft tissue has been removed and/or by using differentamounts of pulling force to remove different types of tissue. Forexample, in one embodiment, if a surgeon only desires to remove softtissue, he/she may apply a first amount of pulling force. If, instead,the user desires to remove only bone tissue, it may be possible to applysufficient force to cut immediately through ligament and address bone.In other embodiments, a user may apply a first amount of tension todevice 160 to remove soft tissue and a second amount of tension toremove bone, within the same procedure. For example, it typicallyrequires approximately 30,000 psi of force to cut cortical bone. Thus,in embodiments where it is desired to cut bone, at least some of blades166 may have bone-cutting tips. In such an embodiment, first majorsurface 165, when bending over a bone surface, may have an active regionwith blades 166 that can be urged into soft tissue (such as ligament),and manual tension forces applied to device 160 divided by a combinedsurface area of the bone cutting tips of blades 166 within the activeregion may be at least 30,000 psi. In an alternative embodiment, atleast some of blades 16 may have bone-protecting ends, and manualtension forces applied to device 160 divided by a combined surface areaof the bone-protecting ends of blades 166 within the active region maybe less than 30,000 psi. Such an embodiment may facilitate removal ofsoft tissue, if blades 166 ride or “skate” over the bone and are thusfocused on soft tissue removal.

Referring to FIG. 24, in one embodiment a tissue modification device 180may include a proximal handle 189 coupled with one end of an elongatebody 182, which includes a proximal rigid shaft portion 183 and a distalflexible portion 184. Multiple substantially vertical, substantiallyin-line blades 186, 186′ may be disposed on a first major surface 185 offlexible portion 184, while a second major surface 187 approximatelyopposite first major surface 185 is substantially atraumatic to inhibitdamage to non-target tissues during a tissue modification procedure.(Again, by “substantially in-line,” it is meant that a side of eachblade is aligned at an angle of between about 0 degrees and about 45degrees relative to the longitudinal axis of the elongate body. By“substantially vertical,” it is meant that each blade forms an anglewith the first surface of the elongate body of between about 45 degreesand about 90 degrees.) Flexible portion 184 may also include a guidewirecoupler 188 at its distal end.

In various embodiments, a number of which are described further below,any suitable combination of blades 186, 186′ may be included on a giventissue modification device. For example, device 180 includes fourpointed-tip blades 186 and two flat-top blades 186′ of various heightsand lengths. Various blades may be configured to perform one or more ofa number of functions. For example, pointed-tip blades 186 may be idealfor removing bone, while flat-top blades 186′ may work best at removingsoft tissue and riding along a bone surface, for example to help steeror guide device 180. In some embodiments, all blades on a device may beconfigured for optimal soft tissue cutting, such as cutting ofligamentum flavum tissue in the spine, while in other embodiments allblades may be configured for optimal bone cutting, such as vertebralbone. Other alternative embodiments may include a combination of bladeshapes and configurations to provide multiple different types ofcutting. Further discussion of blades combinations and configurationsfollows below.

With reference now to FIG. 25, an alternative embodiment of a tissuemodification device 190 may include an elongate body having alongitudinal axis 191, a rigid shaft portion 193 and a flexible portion194. Flexible portion 194 may have a lateral axis 195 and may include aguidewire coupler 198 at or near it distal end. In some embodiments,multiple blades 196, 196′ may be disposed laterally across a first majorsurface 192 of flexible portion 194, with each set of two blades 196,196′ extending from a base 197 coupled with surface 192. The embodimentshown includes pointed-tip blades 196 and flat-top blades 196′. In theembodiment shown, and as described in further detail below in relationto an alternative embodiment, some or all blades 196′ may be angled,relative to elongate body longitudinal axis 191. Angling blades 196′ maycause or facilitate lateral movement of device 190 along a target tissueas device 190 is reciprocated back and forth to modify the tissue, thusproviding for wider or more complete tissue removal.

Referring to FIG. 26, a flexible portion 204 of an alternativeembodiment of a tissue modification device 200 is shown in top view. Inthis embodiment, flexible portion 204 has a longitudinal axis 202, andmultiple sets of blades 206, each set of two blades extending from anassociated base 207, coupled with a first surface of flexible portion204. The sets of blades 206 may be distributed axially alonglongitudinal axis 202 and may also be distributed laterally across thefirst major surface. In the embodiment shown, three blades 206 a arealigned such that their sides are approximately in line withlongitudinal axis 202, while two blades 206 b are angled, such that eachside forms an angle 208 with longitudinal axis 202. Again, such angledblades 206 b may facilitate lateral movement or “steering” of device 200along a target tissue such as soft tissue and/or bone. In variousembodiments, all blades 206 may form an angle of about 0 degreesrelative to longitudinal axis 202 (as with blades 206 a), all blades maybe angled (as with blades 206 b), or device 200 may include acombination of angled and non-angled blades. In some embodiments, eachblade side may form an angle of between about 0 degrees and about 45degrees with longitudinal axis 202 of flexible portion 204. As mentionedpreviously, such blades 206 may be referred to as being “substantiallyin-line.” In a more preferred embodiment, each blade side may form anangle of between about 0 degrees and about 30 degrees relative tolongitudinal axis 202. In various alternative embodiments, any number orcombination of blades, having any combination of angles, positions onflexible portion 204 or the like may be used.

In various embodiments, blades may be distributed in any of a number ofsuitable distances and configurations along the first major surface offlexible portion 204. For example, any number of blades 206 may be usedin various embodiments, such as but not limited to between two and eightsets of two blades 206 each. In some embodiments, blades 206 aredistributed axially along flexible portion 204 at distances selected toconfer a desired amount of flexibility to flexible portion 204.Increased space between the sets of blades, for example, may increasethe flexibility of flexible portions 204, while placing the sets ofblades closer together along longitudinal axis 202 may decreaseflexibility of flexible portion 204.

Referring now to FIG. 27A, one embodiment of a tissue modificationdevice 210 is shown in end-on view at the location of a flexible portion214 with multiple blades 216 coupled with one side. Each set of twoblades 216, in this embodiment, extends from a base 215, and each base215 is coupled with flexible portion 214. As seen in this figure, insome embodiments some or all blades 216 may be laterally offset,relative to one another, along flexible portion 214. Blades 216 ofdevice 210 are substantially vertical, relative to the surface offlexible portion 214 to which they are attached, and they are alsoaligned at approximately a 0 degree angle relative to the longitudinalaxis of flexible body 214. In device 210, blades form approximately a 90degree angle with flexible body 214 and approximately a 0 degree anglewith the longitudinal axis of flexible body 214.

FIG. 27B shows an alternative embodiment of a tissue modification device220, again in end-on view, where rows of closely spaced blades 226 areattached together on flexible portion 224, analogous to the way sharks'teeth are aligned in rows in a shark's mouth. In this embodiment, setsof six blades 226 (three on each side) extend from one base 225, andeach base 225 is coupled with flexible portion 224.

FIG. 27C shows an alternative embodiment of a tissue modification device230 with four, flat-top blades 236 aligned at an angle relative to thelongitudinal axis of flexible portion 234. In this embodiment, each setof two blades 236 extends from an associated base 235.

FIG. 27D shows another alternative embodiment of a tissue modificationdevice 240, including two blades 246 that form an approximately 90degree angle 248 with a first major surface of a flexible portion 244and two blades 246′ that form a more acute angle 248′ with the firstmajor surface. In various embodiments, the sides of each blade may forman angle with the flexible portion of between about 90 degrees and about45 degrees, or more preferably between about 90 degrees and about 60degrees. These angles 248, 248′ may be referred to as “tilt,” and in anygiven embodiment, all blades may be tilted (i.e., all form an angle ofless than 90 degrees with the surface), no blades may be tilted (i.e.,all form an angle of about 90 degrees with the surface), or some bladesmay be tilted and others may not, as in FIG. 27D.

Referring now to FIG. 28, as mentioned previously, in some embodiments,a tissue modification device 250 may have a flexible portion 254including multiple blades 256, some of which may be laterally offsetrelative to one another and others of which may lie along the same linerelative to one another. For example, device 250 includes multipleblades 256, all aligned at approximately 0 degrees relative to alongitudinal axis 252 of flexible portion 254. Blades 256 a and 256 dlie along the same line, relative to each other, as do blades 256 b and256 c. Obviously, blades 256 a and 256 d are offset, relative to blades256 b and 256 c. Blades 256 e and 256 f lie along the same line relativeto one another and are placed close to opposite edges of flexibleportion 254. In various embodiments, any combination of lateralplacement of blades 256 along device 250 may be used. Offsetting blades256 relative to one another may facilitate cutting or shredding of softtissue, for example.

In some embodiments, blades 256 may be shaped and/or axially spaced tofacilitate or enhance the collection of cut tissue between blades 256.(By “axially spaced,” it is meant the longitudinal spacing alonglongitudinal axis 252.) In some embodiments, axial spacing of blades 256may also be optimized to provide a desired flexibility to flexibleportion 254.

With reference now to FIGS. 29A-29E, a method according to oneembodiment is demonstrated for removing tissue using a tissuemodification device 260. FIG. 29A is an end-on, diagrammaticrepresentation of an intervertebral foramen IF, showing vertebral bone,ligamentum flavum LF and nerve root N, with device 260 passing throughthe foramen IF between nerve root N and ligamentum flavum LF. Device 260may have some blades 262 vertically oriented and at approximately a 0degree angle relative to the longitudinal axis of device 260, whileother blades 262′ may be angled, relative to the longitudinal axis.

In FIG. 29B, device 260 has been pulled upward (hollow-tipped arrows) tourge blades 262, 262′ into ligamentum flavum LF so that at least one ofblades 262, 262′ contacts vertebral bone. In some embodiments, some orall of blades 262, 262′ may have a height approximately equal to orgreater than a thickness of an average ligamentum flavum LF.

Referring to FIG. 29C, when device 260 is reciprocated back and forthalong its longitudinal axis, ligamentum flavum LF tissue is removed inone area of the intervertebral foramen IF. As device 260 isreciprocated, angled blades 262′ may steer or guide device 260 laterallyin the intervertebral foramen IF (hollow-tipped arrow). In someembodiments, for example, device 260 may steer to one side when thedevice is pulled in one direction and steer to the other side when thedevice is pulled in the opposite direction.

In FIG. 29D, device 260 has moved toward the opposite lateral side ofthe intervertebral foramen IF (hollow-tipped arrow) to remove additionalligamentum flavum LF tissue. In some embodiments, any or all blades 262,262′ of device 260 may have flat tops, which may help blades 262, 262′to slide or “skate” across the surface of bone as device 260 isreciprocated to cut through soft tissue. This sliding or skating motionmay also help device 260 move from side to side within theintervertebral foramen IF.

In FIG. 29E, much of the ligamentum flavum LF has been removed, andblades 262, 262′ are in a position to treat bone. In some cases, aphysician may choose to continue using device 260 to remove bone, whilein other cases a physician may wish to remove mostly or exclusivelyligamentum flavum LF tissue. In various embodiments, the physician maydetermine when a desired amount of soft tissue and/or bone is removed byusing tactile feedback from device 260, by removing device 260 toexamine tissue trapped in device 260, by radiographic visualization suchas fluoroscopy, by use of one or more sizing probes or other instrumentsto gauge the size of the intervertebral foramen IF, or any combinationof such methods.

When a desired amount of tissue has been removed, device 260 may beremoved from the patient to complete the procedure. As mentioned, insome embodiments, device 260 may be used to remove only ligamentumflavum LF tissue and then removed from the patient to end the procedure.In alternative embodiments, device 260 (or a differently configureddevice) may be used to remove both soft tissue and bone. In yet anotheralternative embodiment, a first device (for example, device 260) may beused to remove ligamentum flavum LF tissue, the first device may beremoved from the patient, and a second device may be inserted and usedto remove bone. Thus, in some embodiments, two different devices may beused in one procedure, with one device optimized for soft tissue removaland another device optimized for bone removal.

With reference now to FIGS. 30-33, various embodiments of bladestructures are shown. For example, in an embodiment as in FIG. 30, ablade structure 270 may include two blades 272 extending substantiallyvertically from a base 274. In some embodiments, each set of two blades272 and their associated base 274 may be made from one piece ofmaterial, with each blade 272 bending upward from base 274. Base 274 mayprovide a surface for attaching blades 272 to one side of a tissuemodification device, such as my welding, attaching via adhesive and/orthe like. In one embodiment, blades 272 may have beveled cutting edgesand pointed tips, as shown, although any of a number of other bladeconfigurations may alternatively be used.

In an alternative embodiment, as in FIG. 31, a blade structure 280 mayagain include two blades 282 extending substantially vertically from abase 284. In this embodiment, blades 282 have beveled edges and a flat,beveled top.

In another alternative embodiment, as in FIG. 32, a blade structure 290may include any number of blades 292 coupled with a base 294. In thisembodiment, twelve blades 292 are coupled with base 294, and base 294has a back-and-forth (or “zig-zag”) configuration.

In another alternative embodiment, as in FIG. 33, a blade structure 300may include eight, flat-top blades 302 (or any other suitable number)coupled with a base 304 having a diagonal configuration. When base 304is attached to a surface of a tissue modification device, blades 302 maybe angled and/or laterally offset due to the diagonal configuration ofbase 304.

Referring now to FIG. 34, one embodiment of a tissue modification device310 may include an elongate body flexible portion 312 and multipleblades 314 attached to one side of flexible portion 312 such that eachblade 314 has a height 316 and a length 319, and such that a distancebetween two blades 314 defines a pitch 318. As mentioned previously, invarious embodiments, blades 314 may have any of a number of shapes, suchas pointed-tip 314 a, 314 b and flat-top 314 c, 314 d. Each blade 314may also have a height 316, which may be defined as a distance betweenof first end of the blade 314, which is coupled with a first surface offlexible portion 312, and a second, cantilevered end of the blade 314.In some embodiments, for example, blades 314 have each have a heightranging from about about 0.5 mm to about 2.0 mm. In some embodiments,two or more blades may have different heights relative to one another.In one embodiment, for example, one or more sets of blades 314 may havea height optimized for addressing bone and one or more other sets ofblades 314 may have a height optimized for addressing soft tissue. Inone embodiment, shorter blades 314 may be positioned more distally onflexible portion 312, relative to higher blades 314 positioned moreproximally. This placement of blades 314 may facilitate entry of device310 into a tight anatomical location on a patient or around a tightcorner.

Length 319 of each blade 314 may be defined as a distance between twoblade edges. In various embodiments, blades 314 may have any suitablelengths, and a variety of blade lengths may be used in the sameembodiment. Blades 314 may also have a pitch 318, defined as a distancefrom the beginning of an edge of one blade 314 a to the beginning of anedge of a next adjacent blade 314 b along device 310. In someembodiments, for example, pitch 318 may range from about 0.5 mm to about4.0 mm. In various embodiments, any suitable combination of bladeshapes, heights 316, lengths 319 and pitches 318 may be used.

With reference now to FIG. 35, in another embodiment, a tissuemodification device 320 may include multiple blades 324 formed directlyout of a flexible portion 322, thus creating an opening 326 in flexibleportion 322. For example, blades 324 may be cut and bent out of flexibleportion 322. Flexible portion 322 may also include a guidewire coupler323. In this embodiment, flexible portion 322, blades 324 and guidewirecoupler 232 are formed from one piece of material.

Referring to FIG. 36, in another alternative embodiment, multiplesubstantially vertical, substantially in-line blades 334 may be formedin a flexible portion 332 of a tissue modification device by cuttingmultiple flaps in flexible portion 332 and pulling them up to formblades 334 (curved, hollow-tipped arrows). In some embodiments, flexibleportion 332 may be curved.

Referring now to FIGS. 37-54, a number of different embodiments ofblades, which may be included in various embodiments of tissuemodification devices, are shown. This is not meant to be anall-inclusive list, but instead is provided for exemplary purposes.Thus, other blades shapes and configurations not shown in FIGS. 37-54may also be used in various embodiments of tissue modification devices.

The blade embodiments shown and described below generally have more thanone cutting edge, and generally each edge of each blade is a cuttingedge. In various alternative embodiments, however, a blade may havemultiple edges, but not all the edges need be cutting edges. Forexample, in some embodiments a blade may have a cutting edge on one sideand a dull edge on an opposite side, thus acting as a one-directioncutting blade. In another embodiment, a blade may have a front edge, aback edge and a top edge, and only the front and back edges might becutting edges, with the top edge being dull, for example to facilitatethe blade's riding along a bone surface. Generally, any edge of a bladedescribed below may be, in alternative embodiments, a cutting edge or anon-cutting edge. Cutting edges, generally, may have any of a number ofdifferent configurations, such as beveled, pointed, serrated,saw-toothed and the like. Non-cutting edges may also have any of anumber of different configurations, such as squared, rounded, notched orthe like.

The blades of FIGS. 37-40 are all generally triangle-shaped. FIG. 37shows a triangle-shaped, pointed-tip blade 340 with tapered cuttingedges. FIG. 38 shows a triangle-shaped, pointed-tip blade 346 withstraight cutting edges. FIG. 39 shows a triangle-shaped, pointed-tipblade 352 with downward-facing barbs on two cutting edges. FIG. 40 showsa triangle-shaped, pointed-tip blade 358 with saw-tooth cutting edges.

FIGS. 41 and 42 show square-shaped blades. FIG. 41 shows a square-shapedblade 364 with a flat-top cutting edge and straight vertical cuttingedges. FIG. 42 shows a square-shaped blade 370 with straight verticalcutting edges and a crown-shaped (or serrated or saw-tooth) upperhorizontal cutting edge.

The blades in FIGS. 43-45 all have convex-shaped upper cutting edges. InFIG. 43, blade 376 has a convex upper cutting edge and concave lateralcutting edges. In FIG. 44, blade 382 has a convex upper cutting edge andstraight lateral (or vertical) cutting edges. In FIG. 45, blade 388 hasa convex, crown-shaped (or serrated or saw-tooth) upper cutting edge andstraight lateral cutting edges.

The blades in FIGS. 46-48 are all wave-shaped. The blade 394 of FIG. 46has a wave shape and two smooth cutting edges. The blade 400 of FIG. 47has a wave shape, one smooth cutting edge and one saw-tooth (orserrated) cutting edge. The blade 406 of FIG. 48 has a wave shape andtwo saw-tooth cutting edges.

FIGS. 49-51 all show rounded blades. In FIG. 49, blade 412 is roundedwith a smooth cutting edge. In FIG. 50, blade 418 is rounded withdownward facing barbs along a portion of its cutting edges. In FIG. 51,blade 424 is rounded with a saw-tooth (or serrated) cutting edge.

The blades of FIGS. 52-54 are all trapezoidal in shape. In FIG. 52,blade 430 has a trapezoidal shape and straight/smooth cutting edges. InFIG. 53, blade 436 has a trapezoidal shape and saw-tooth (or serrated)cutting edges. In FIG. 54, blade 442 has a trapezoidal shape andstraight lateral cutting edges with a saw-tooth (or serrated) uppercutting edge. Again, the foregoing examples are provided for exemplarypurposes, and in various embodiments, tissue modification devices mayinclude any alternative blade shapes and configurations.

FIGS. 55-60 are cross-sectional views of a number of different bladeembodiments, looking from an end-on perspective. According to variousembodiments, blades may have any of a number of different upper cuttingsurfaces, and FIGS. 55-60 illustrate several examples of such surfaces.In FIG. 55, for example, blade 450 includes an upper cutting edge havinga double-bevel configuration. The blade 454 in FIG. 56 has asingle-bevel upper cutting edge 456. In FIG. 57, blade 458 has a taperedshape that ends in upper cutting edge 460.

In some embodiments, a blade may have an upper surface that is not sharpor pointed. Such an upper surface may help such a blade to slide orskate off of a bony surface, thus facilitating steering of a tissuemodification device. For example, in FIG. 58, blade 462 has a flat uppersurface 464. In FIG. 59, blade 466 has a rounded (or convex) uppersurface 468. In FIG. 60, blade 470 has a concave upper surface 472.Again, any other suitable blade shape may be used in various alternativeembodiments.

In various embodiments, any given flexible tissue modification devicemay act on tissue in a number of different ways, such as by cutting,ablating, dissecting, repairing, reducing blood flow in, shrinking,shaving, burring, biting, remodeling, biopsying, debriding, lysing,debulking, sanding, filing, planing, heating, cooling, vaporizing,delivering a drug to, and/or retracting target tissue. For example, manyof the devices described above may also optionally be loaded with adrug, bone wax, gel foam, or the like, which may be deposited during atissue modification procedure. Any suitable drug may be delivered viathe devices in various embodiments, such as but not limited to thrombin,NSAID, local anesthetic or opioid. In some embodiments, devices may alsodeliver an implant, such as a stent-like implant for maintaining patencyof decompressed intervertebral foramen, a rivet, staple or similardevice for retracting ligamentum flavum tissue, a tissue dressing, orthe like. In some embodiments, devices may cool or freeze tissue foranalgesia or to change the tissue's modulus of elasticity to facilitatetissue modification. Some embodiments of devices may also include avisualization and/or diagnostic component, such as an ultrasound, MRI,reflectance spectroscopy, fiber optic, endoscope, charge-coupled device(CCD), complementary metal-oxide semiconductor (CMOS) or other device.

Any of the devices described herein may also optionally include one ormore components for neural identification and/or localization. Forexample, in some embodiments, a flexible tissue modification device mayinclude one or more nerve stimulation electrodes on a backside orunderside of the device (i.e., a side designed to be atraumatic and facenon-target tissue). The electrode(s) may be used to confirm that theatraumatic side of the device is in contact with non-target neuraltissue, thus also confirming that the tissue modification members of thedevice are facing target tissue. In some embodiments, the devices mayalso include one or more electrodes on an upper surface, at or near thetissue modification members, to further confirm a desired placement ofthe device. For further description of such neural localization devicesand methods, reference may be made to U.S. patent application Ser. No.11/457,416 (now U.S. Pat. No. 7,578,819), which was previouslyincorporated by reference.

In various alternative embodiments, any of the tissue modificationdevices and method described above may be used in combination with oneor more vertebral distraction devices. In one embodiment, for example,an interspinous implant such as the X STOP® implant (offered by St.Francis Medical Technologies, Inc., Alameda, Calif., www.sfmt.com) maybe inserted between adjacent vertebrae, and then access devices and/ortissue removal devices described herein may be used to remove orotherwise modify spinal tissue. Such an implant may be inserted and leftin place after a procedure, while in alternative embodiments adistraction device may be used only during a tissue removal procedure.Various embodiments and aspects of such distraction/tissue removalcombinations are described in greater detail in U.S. Provisional PatentApplication No. 60/884,37, titled “Spinal Stenosis Treatment Methods andApparatus,” filed Jan. 10, 2007, the full disclosure of which is hereinincorporated by reference in its entirety.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

What is claimed is:
 1. A method for modifying a target bone of a bonejoint in a patient, the method comprising: advancing a guidewire intothe body and adjacent to the target bone of a bone joint so that theguidewire passes along a path through the patient where the proximal endof the guidewire extends from a first position outside of the patient'sbody and the distal end of the guidewire extends from a second positionoutside of the patient; coupling the proximal end of the guidewire to atissue modification device outside of the body after advancing theguidewire into the body, wherein the tissue modification device is formodifying bone tissue and comprises an elongate flexible body having atissue-modifying active region; pulling the tissue modification devicebehind the guidewire along the path to position the active region of thetissue modification device adjacent to the target bone of the bonejoint, wherein the proximal end of the guidewire remains within thebody; urging the active region of the tissue modification device againstthe target bone by manually reciprocating the elongate body axiallyalong the path while a portion of the guidewire remains within the body;and wherein coupling the proximal end of the guidewire comprisescoupling the proximal end of the guidewire to a tapered distal endregion of the tissue modification device.
 2. The method of claim 1,wherein the target bone comprises spine.
 3. The method of claim 1,wherein the target bone comprises hip.
 4. The method of claim 1, whereinthe target bone comprises bone of a sacro-iliac joint.
 5. The method ofclaim 1, wherein urging comprises reciprocally applying pulling force ator near opposite ends of the elongate body.
 6. The method of claim 1,further comprising reciprocating the elongate body to remove a portionof the target bone.
 7. The method of claim 1, wherein pulling the tissuemodification device comprises advancing the elongate body percutaneouslyinto the patient by pulling the device behind the guidewire.
 8. Themethod of claim 1, further comprising inhibiting damage to a non-targettissue with an atraumatic surface of the elongate body configured tocontact the non-target tissue when the blades contact target tissue. 9.The method of claim 1, wherein urging the active region comprisesreciprocating the elongate body axially along the path by alternatelyapplying a manual pulling force to a handle at a distal end of theguidewire and applying a manual pulling force to a handle a proximal endof the tissue modification device.
 10. The method of claim 1, whereinurging the active region comprises reciprocating the elongate bodyaxially along the path by alternately applying a manual pulling force toa handle at a distal end of the guidewire and applying a manual pullingforce to a handle a proximal end of the tissue modification device,wherein the distal handle and the proximal handle move in oppositedirections relative to the outside of the patient's body such that onehandle moves toward the body while the other handle moves away from thebody.
 11. The method of claim 1, wherein the tissue-modifying activeregion of the tissue modification device comprises a plurality ofblades.
 12. The method of claim 1, wherein the tissue-modifying activeregion of the tissue modification device comprises an abrasive surface.13. The method of claim 1, wherein urging the active region of thetissue modification device against the target bone comprises abradingthe target bone.
 14. A method for modifying a target bone of a bonejoint in a patient, the method comprising: advancing a guidewire intothe body and adjacent to the target bone so that the proximal end of theguidewire extends from a first position outside of the patient's bodyand the distal end of the guidewire extends from a second positionoutside of the patient; coupling the proximal end of the guidewire to atissue modification device outside of the body after advancing theguidewire into the body, wherein the tissue modification device is formodifying bone and comprises an elongate flexible body having a tissuemodifying active region at or near a distal end of the tissuemodification device; pulling the tissue modification device into thebone joint behind the guidewire to position the active region adjacentthe target bone, wherein the proximal end of the guidewire remainswithin the body; abrading the target bone by alternately pulling on theproximal end of the tissue modification device and the guidewire tomanually reciprocate and urge the active region against the bone whilethe proximal end of the guidewire remains within the body; and whereincoupling the proximal end of the guidewire comprises coupling theproximal end of the guidewire to a tapered distal end region of thetissue modification device.
 15. The method of claim 14, wherein thetarget bone comprises spine.
 16. The method of claim 14, wherein thetarget bone comprises hip.
 17. The method of claim 14, wherein thetarget bone comprises bone of a sacro-iliac joint.
 18. The method ofclaim 14, wherein pulling the tissue modification device comprisesadvancing the elongate body percutaneously into the patient by pullingthe device behind the guidewire.
 19. The method of claim 14, furthercomprising inhibiting damage to a non-target tissue with an atraumaticsurface of the elongate body configured to contact the non-target tissuewhen the blades contact target tissue.
 20. The method of claim 14,wherein abrading the target bone comprises reciprocating the elongatebody axially by alternately applying a manual pulling force to a handleat a distal end of the guidewire and applying a manual pulling force toa handle a proximal end of the tissue modification device.
 21. Themethod of claim 14, wherein the active region of the tissue modificationdevice comprises a plurality of blades.
 22. The method of claim 14,wherein the active region of the tissue modification device comprises anabrasive surface.